Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Shots:

  • The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN
  • The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice as fast as SoC, complete renal response @24 wks vs SoC @1year
  • Lupkynis is the 1st FDA-approved oral therapy for LN and is now commercially available in the US

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Aurinia Pharmaceuticals

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Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

Shots:

  • The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC.
  • Results: @ median follow-up of 18.1 mos. patients treated with the combination achieved PFS of 16.6 mos vs 8.3 mos for Sutent arm. Opdivo + Cabometyx also significantly reduced the risk of death by 40% vs Sutent alone , ORR 56% in combination and 27% sunitinib
  • Application approved prior to PDUFA action date of Feb 20, 2021 and reviewed under the Real-Time Oncology Review pilot program

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Fierce Pharma

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Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Shots:

  • The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ advanced NSCLC prior not treated with an ALK inhibitor
  • The therapy showed effectiveness in patients undergoing 1L & 2L treatment for ALK+ NSCLC including efficacy in patients with brain metastases.
  • Alunbrig is a potent and selective next-generation TKI designed to target ALK molecular alterations and is approved in 30+ countries including the US & EU

Click here ­to­ read full press release/ article | Ref: Takeda | Image: The Boston Globe

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ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Shots:

  • The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen
  • Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for ~1mos. to assess the tolerability of each therapy. The therapy reduces the treatment dosing days from 365 days to 12days/ yr
  • The company will begin shipping of Cabenuva to wholesalers and specialty distributors in the US in Feb’2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: ViiV Healthcare

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Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Shots:

  • The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event
  • The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in annualized absolute risk. The 1EPs is time to the first event of CV death or hospitalization for HF @median follow-up of 11 mos.
  • Verquvo is the first soluble guanylate cyclase stimulator, approved to treat HF

Click here ­to­ read full press release/ article | Ref: Business Wire| Image: Financial Times

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AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK

Shots:

  • Imfinzi has been approved in the EU and the UK for an additional dosing option (1500mg, fd, q4w) in LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT
  • New option extends dosing from 2 to 4wks. thus, reducing medical visits and improving patient convenience. The approval is based on multiple clinical trials that include P-III PACIFIC study in NSCLS patients and P-III CASPIAN study in ES-SCLC patients
  • Durvalumab is a human mAb targeting PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Business Standard

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Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Shots:

  • The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment
  • The therapy is currently being evaluated in ongoing P-III program including PEARL 1 & -2 that assess Ligelizumab vs Xolair (omalizumab) in ~2000 patients across the globe with its anticipated results in H2’21
  • Ligelizumab is a next generation monoclonal anti-IgE Ab, that demonstrated more patients experienced complete resolution of wheals (hives) in a P-IIb dose-finding trial. The company is anticipating the US regulatory submission in 2022

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Medical, Marketing and Media

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BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Shots:

  • The approval is based on Tislelizumab + CT regimen vs CT as monothx. in 360 patients with a ratio (1:1:1) as a 1L for patients with advanced squamous NSCLC
  • The trial met the 1EP, i.e. improvement in PFS, as assessed by IRC in the pre-planned interim analysis. The safety profile of tislelizumab in both combinations was consistent with the known risks of each study treatment, and no new safety signals were identified
  • Tislelizumab is a humanized IgG4 anti-PD-1 mAb specifically designed to minimize binding to FcγR on macrophages. The approval marks the third approval for tislelizumab in China and its first in a lung cancer indication

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Memorial Sloan Kettering Cancer Center

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Lundback’s Vyepti (eptinezumab, IV) Receives Health Canada’s Approval for Preventive Treatment of Migraine

Shots:

  • The approval follows P-III trials (PROMISE-1 in episodic migraine & PROMISE-2 in chronic migraine) assessing Vyepti vs PBO in 2,076 adult patients for the preventive treatment of migraine who have at least 4 migraine days/mos.
  • The studies met its 1EPs of decrease in mean monthly migraine days (MMD) over 1-12wks and showed 50% & 75% responder rates & good tolerability
  • Vyepti is a humanized mAb that binds to calcitonin gene-related peptide (CGRP)

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BT

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Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza

Shots:

  • The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged≥12yrs.
  • The approval follows the CHMP’s positive opinion for Xofluza and is based on P-III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies
  • Xofluza is a first-in-class, single-dose oral therapy, reduces the societal burden of influenza with a rapid reduction in viral replication

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Krauthammer

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Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test

Shots:

  • The US FDA has granted EUA to Nirmidas’ COVID-19 rapid antibody IgG/IgM test for use in POC settings, delivering results in 15-20min
  • Using a fingerstick serology test, the MidaSpot COVID-19 Ab combo detection kit checks for Ab against the RBD antigen and showed 100% sensitivity for IgG after 14 days post symptom onset and 100% sensitivity for IgM after 7 days post symptom onset
  • With this, Nirmidas became the first US company to receive EUA for a COVID-19 POC fingerstick Ab test. The kit can now be administered in CLIA-waived settings for POC testing such as doctor’s offices, pharmacies, ERs

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Yahoo Finance

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Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

Shots:

  • The BTD is based on P-II CITYSCAPE study assessing Tiragolumab + Tecentriq vs Tecentriq + PBO as a 1L treatment of 135 patients in a ratio (1:1) with LA unresectable metastatic NSCLC whose tumors have high PD-L1 expression with no EGFR
  • Result: improvement in ORR (37% vs 21%); reduction in the risk of disease worsening or death (42%); ORR (66% vs 24%); m-PFS (not reached vs 4.11 mos.); Grade 3 AEs (48% vs. 44%)
  • Tiragolumab is a mAb designed to bind with TIGIT and works as an immune amplifier, by potentially enhancing the body’s immune response. The company is evaluating the tiragolumab across various settings in different tumor types, including lung, esophageal and cervical cancers

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: Magic Number IP

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AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19

Shots:

  • India has granted the emergency use approval for AstraZeneca and the Oxford University’s COVID-19 vaccine developed by a day after an advisory panel of CDSCO issued its recommendation
  • Covishield would be the first vaccine to be given the go-ahead by drug regulators in India. SII and AstraZeneca have partnered up to manufacture and distribute the vaccine in India and several other countries
  • Discussion for the EUAs are underway for Bharat Biotech’s COVAXIN, Zydus Cadila’s ZyCoV-D, and Russia’s Sputnik-V. India plans to inoculate 300M of its 1.35B people in the first six to eight months of 2021

Click here ­to­ read full press release/ article | Ref: Hindustan Times | Image: The Economic Times

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AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK

Shots:

  • The MHRA has provided authorization for an emergency supply of AZD1222, for the active immunization of individuals aged ≥18yrs. The approval recommends 2 doses administered with an interval of between 4 & 12wks
  • The authorization is based on independent advice from its CHM following a rolling review of trial data that included an interim analysis of the P-III program led by the University of Oxford
  • AstraZeneca aims to supply millions of doses in Q1 as part of an agreement with the government to supply ~100M doses in total. The company will continue the regulatory interactions across the globe for the next approvals

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Express Pharma

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Casi and Juventas Cell Therapy’s CNCT19 (CD19 CAR-T) Receives China NMPA’s BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots:

  • The BT (breakthrough therapy) Designation was based on initial data for ongoing single-arm, open-label, non-randomized, dose-escalation, P-I study for safety and efficacy in B-ALL
  • The BT Designation procedure is under NMPA’s revised Drug Registration Regulation with effect from Jul 1, 2020. It is designed to expedite the development of treatment of diseases with no existing treatment and evidence indicates the benefit of the therapy vs available treatment
  • CNCT19 targets CD19 is a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CNCT19 is currently being developed by Casi and Juventas Cell Therapy

Click here ­to­ read full press release/ article | Ref: Casi Pharmaceuticals  | Image: Casi Pharmaceuticals

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Amyrt’s AP103 Receives the US FDA’s Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB)

Shots:

  • The US FDA has granted orphan drug designation for AP103 for the treatment of DEB
  • Amyrt licensed a pre-clinical gene – therapy platform technology to treat patients with DEB, a subset of EB also applicable for genetic disorders in Mar 2018
  • AP103 is based on a novel polymer-based topical delivery platform and offers potential advantages in the gene therapy field also used in other genetic skin conditions

Click here ­to­ read full press release/ article | Ref: GlobeNewswire  | Image: Twitter

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Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

Shots:

  • The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics, efficacy, and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery)
  • Result of FeDeriCa Study: The GMR for the 1EPs (1.22) with the lower limit (90%) CI of the GMR (1.14≥0.80). 2EPs of non-inferior levels of Herceptin was also met with blood conc. GMR (1.33) with the lower limit (90%)
  • Phesgo combines the same mAb as Perjeta and Herceptin with Halozyme Therapeutics Enhanze drug delivery technology in a novel formulation for SC use

Click here ­to­ read full press release/ article | Ref: Roche  | Image: Fierce Biotech

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Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma

Shots:

  • The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma are eligible for (ASCT)
  • Result: The 1EPs of sCR rate post-transplant was significantly higher (29 % vs. 20 %); median follow-up (18.8 mos.); reduction in the risk of disease progression or death (53%)
  • Darzalex is the first CD38-directed mAb approved to treat multiple myeloma. The subcutaneous formulation was approved by Health Canada to treat patients with multiple myeloma in 2020

Click here ­to­ read full press release/ article | Ref: Newswire.CA  | Image: Philadelphia Inquirer

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Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Shots:

  • The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine
  • The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose
  • The CMA is valid in all 27 member states of the EU while the companies are ready to immediately ship initial doses to all the member state

Click here ­to­ read full press release/ article | Ref: BusinessWire  | Image: Market Place

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Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

Shots:

  • The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers
  • Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were similar. The frequency of injection site reactions and AEs were comparable in participants who were dosed with IM followed by SC, compared to SC followed by IM
  • The approval expands the offerings to the individuals with RMS, providing treatment option combining safety & efficacy to optimize the treatment experience with a reduction in injection site reactions

Click here ­to­ read full press release/ article | Ref: Biogen  | Image: The New York Times

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AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Shots:

  • The approval is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated
  • Results: reduction in the risk of disease recurrence (83%); DFS results in the overall trial population in reducing the risk of disease recurrence (80%); @2 yrs. disease-free and alive patients (89% vs 52%)
  • Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases and has received the US FDA BTD for patients in the early-stage disease setting. The therapy is under PR in China and regulatory review in the EU

Click here ­to­ read full press release/ article | Ref: BusinessWire  | Image: Marketwatch

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Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Shots:

  • The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while Moderna will continue to gather additional data and plans to file BLA for full licensure in 2021
  • Allocation and distribution will be prioritized according to populations identified by the CDC’s ACIP. The Company expects to have b/w 100-125M doses available globally in the Q1’21, with 85-100M of those available in the US
  • The US govt. ordered total 200M doses to date & retains an option to purchase up to an additional 300M doses, ~20M doses will be delivered by the end of Dec 2020

Click here ­to­ read full press release/ article | Ref: Moderna | Image: CTech

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Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

Shots:

  • The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden
  • The WAC of Riabni will be 23.7% lower than the Rituxan in the US and will be available at a WAC of $716.80/ 100mg and $3,584.00/ 500mg single-dose vial
  • Riabni is a biosimilar to Rituxan, approved for the treatment of NHL, CLL, GPA, MPA and ill be made available in the US in Jan 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Adweek

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Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

Shots:

  • Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology and dermatology
  • A patient support program will be available to patients treated with Hyrimoz providing guidance with reimbursement navigation, financial assistance, administrative support & education for patients
  • Hyrimoz is a fully human TNF blocker. The notice of compliance has been issued for 3 SC dosage forms: 40 mg/0.8 mL & 20 mg/0.4mL in prefilled syringe, 40 mg/0.8 mL in autoinjector

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: PRNewswire

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Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Shots:

  • The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs
  • The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy
  • The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation into consideration in making a final decision on approval

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Pharmaphorum

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Kite’s Tecartus (KTE-X19) Receives EC’s Conditional Marketing Authorization for R/R Mantle Cell Lymphoma

Shots:

  • The approval is based on P-II ZUMA-2 study assessing Tecartus in 74 patients with r/r MCL prior treated with anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
  • The study demonstrated an OR rate (93 %) with CR (67%), as assessed by an Independent RRC following a single infusion. In safety analyses, Grade 3 or higher CRS and neurologic events in 15% and 33% of patients
  • Tecartus is the first CAR T therapy in r/r MCL. With the approval, Kite becomes the first company with multiple approved cell therapies in the EU

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Glassdoor

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Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

Shots

  • The Health Canada has approved Zolgensma (onasemnogene abeparvovec) for pediatric patients with 5q SMA with bi-allelic mutations in the SMN1 gene and 3 or fewer copies of SMN2 gene or infantile-onset SMA
  • The efficacy and safety data supporting the approval of Zolgensma are derived from completed and ongoing studies in patients with SMA and 2 copies of SMN2 gene and presymptomatic genetically diagnosed SMA and 2 or 3 copies of SMN2 gene
  • Zolgensma (IV) is a gene therapy designed to address the genetic root cause of SMA by replacing the missing or defective SMN1 gene

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Bloomberg

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Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

Shots:

  • The US FDA’s CRDAC voted 12 to 1 supporting the use of Entresto (sacubitril/valsartan) in the treatment of patients with HFpEF
  • The decision was based on efficacy & safety analyses, including findings from a pre-specified subgroup analysis of PARAGON-HF (P-III study in HFpEF) and additional evidence from PARAMOUNT (P-II trial in HFpEF), as well as PARADIGM-HF (P-III trial in HFrEF)
  • Entresto (sacubitril/valsartan) is a prescription medicine used to reduce the risk of CV death & heart failure hospitalization in people with long-lasting heart failure

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioSpace

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Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

Shots:

  • Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response
  • The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% specificity & 99.35% sensitivity in patients tested 15 days or more after symptoms began
  • The test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott plans to submit its test for US FDA’s EUA imminently

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Street

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Ellume’s COVID-19 Home Test Receives the US FDA’s EUA as First Over-the-Counter Diagnostic Test

Shots:

  • The US FDA has granted EUA for Ellume COVID-19 home test for non-prescription home use in symptomatic and asymptomatic individuals aged ≥2yrs.
  • The data submitted to the US FDA from an independently run, simulated home-setting clinical study of 198 subjects aged 2-82yrs, demonstrated 96% accuracy including 95% overall sensitivity & 97% specificity vs emergency use-authorized RT-PCR lab test
  • The test’s core technology combines ultra-sensitive optics, electronic software to leverage digital immunoassay technology with next-generation multi-quantum dot fluorescence technology

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: MobiHealth News

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Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

Shots:

  • OsteoBoost receives the US FDA’s BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at a precise, individually calibrated frequency, encouraging the body to reduce bone resorption & potentially create new bone
  • An initial study showed that just one 30min treatment with OsteoBoost reduced bone loss activity in all participants, showing a decrease of 14%, a reduction on par with bisphosphonate drugs
  • The NIH funded a $2M to study for determining the positive effects of OsteoBoost in a larger study with a broader population. The larger study is currently enrolling patients & is scheduled to be completed in early 2022

Click here ­to­ read full press release/ article | Ref: Bone Health Tech | Image: Linkedin

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Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp

Shots:

  • The approval is based on P-III studies KX01-AK-003 and KX01-AK-004 that evaluated the efficacy and safety of Klisyri (tirbanibulin, ointment 1%, 10 mg/g) vs vehicle in 702 adult patients in the ratio of (1:1) with actinic keratosis of the face or scalp
  • Both the studies achieved their 1EPs defined as 100% clearance of the AK lesions @57 days within the treatment areas, complete clearance (44% vs 5% and 54% vs 13%) respectively
  • Klisyri is the first FDA approved product for Athenex and will be launched in partnership with Almirall in the US during Q1’21

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Athenex

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Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

Shots:

  • The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose of single 600mg infusions were administered over a shorter, 2hrs. time
  • Results: frequency of IRRs post 600mg infusion (24.6% vs 23.1%), majority of IRRs were mild or moderate, and >98% resolved in both groups without complication
  • Ocrevus is a humanized mAb designed to target CD20-positive B cells and is the first and only therapy approved for both RMS and PPMS

Click here ­to­ read full press release/ article | Ref: Genentech | Image: Xconomy

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AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

Shots:

  • The approval is based on P-lll ETHOS involve the assessing of Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) vs Bevespi Aerosphere and PT009 in adult patients with mod. to sev. COPD. P-III KRONOS study also supported the approval
  • The study showed a reduction in rate of mod. or sev. exacerbations. EMA’s CHMP has recommended the MAA for Trixeo Aerosphere in Oct’2020
  • Trixeo Aerosphere is a single-inhaler, fixed-dose triple-combination of formoterol fumarate LABA, LAMA, with budesonide, an ICS, and delivered in a pressurized metered-dose inhaler. The approval marks the fourth major approval of the therapy

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Global Justice Now

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Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

Shots:

  • Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared to file a planned BLA with the US FDA anticipating full approval in 2021
  • The EUA is based on P-III pivotal study demonstrating 95% efficacy in participants without prior SARS-CoV-2 infection & also in participants with/ out prior infection
  • In Jul 2020, the companies collaborated with the HHS & DoD to meet the Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Financial Times

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Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Shots:

  • Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the NACI
  • BioNTech will hold the regulatory approval in Canada while Pfizer will have the commercialization rights. The approval is based on data that was filed through the rolling submission regulatory pathway and data from the P-l/ll clinical trial that began recruiting in Jul’2020 & enrolled ~44,000 patients across ~150 sites in multiple countries
  • The companies will supply ~20M doses of vaccine to Canada through 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Bloomberg Quint

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Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Shots:

  • The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with CT and/or immunotherapy
  • The company is currently recruiting in a P-III study (CodeBreaK 200) assessing sotorasib vs docetaxel in patients with KRAS G12C-mutated NSCLC. Amgen has several P-Ib combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment
  • Sotorasib has also accepted into FDA’s Real-Time Oncology Review Pilot Program. Additionally, the company plans to submit the NDA to the US FDA by the end of 2020

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioSpace

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Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Shots:

  • Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes
  • The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning
  • The technology sustains performance for ~14days, providing trends, insights & actionable data on a reader or with the FreeStyle LibreLink mobile app. FreeStyle Libre 2 will be available for people with diabetes aged ≥4yrs. in Canada in the coming months

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioSpace

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Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Shots:

  • Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
  • The MHRA’s decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
  • This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec’2020

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Jakarta Post

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Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

Shots:

  • The approval is based on P-I/II ARROW study involve assessing Gavreto (400mg, qd) n people with rearranged during transfection (RET) fusion-positive NSCLC, RET-mutant MTC, RET fusion-positive thyroid cancer, and other RET-altered solid tumors
  • The study demonstrated durable clinical activity in people with/out prior therapy and regardless of RET alteration genotypes
  • Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations

Click here ­to­ read full press release/ article | Ref: Roche | Image: Fierce Biotech

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Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Shots:

  • The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
  • Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
  • Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair

Source1, Source2 ­to­ read full press release/ article | Ref: Genentech & Novartis | Image: Dr. Thomas Chacko

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Sanofi’s Dupixent (dupilumab) Receives EC’s Approval for Children with Severe Atopic Dermatitis

Shots:

  • The EC’s approval is based on a P-III study assessing Dupixent (300mg, q4w & 200mg, q2w) + TCS vas TCS alone in children aged 6-11yrs. with severe AD
  • Result: improvement in disease extent and severity (82% & 80% vs 49% & 48%); at least 75% improvement (70% & 75% vs 17% & 26%); skin clearance (33% & 39% vs 11% & 10%); reduction in itching (51% & 61% vs 12% & 13%); improvement in HR-QoL (77% & 81% vs 39% & 36%) respectively
  • Dupixent is mAb that inhibits the signaling of IL-4 and IL-13 proteins and is the only systemic medicine approved in the EU to treat children with severe AD

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: BioSpace

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AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

Shots:

  • The approval is based on a DAPA-HF trial assessing Forxiga (10mg, qd) + SOC vs PBO + SOC in 4,744 patients with HFrEF (LVEF ≤ 40%) with/ out T2D
  • The study demonstrated reduced the risk of the composite outcome by 26% along with a reduction in the risk of CV death or worsening of HF events, including hospitalization for HF
  • Additionally, Forxiga is currently being tested for HFpEF in the P-III DELIVER trial with data readout anticipated in the H2’21

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: ABC News

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AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Shots:

  • The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were judged to be unsuitable for local treatment
  • Result: The proportion of patients achieving at 100 (targeted PG ulcer healed) of the target PGAR @26wks. of administration (54.5%)
  • The indication marks Humira’s 12th indication in Japan and making it the world’s first drug indicated for the treatment of PG. Humira has received MHLW’s ODD for the treatment of PG in 2019

Click here ­to­ read full press release/ article | Ref: Eisai | Image: Owned

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Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

Shots:

  • The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was living with someone with an influenza infection confirmed by a rapid influenza diagnostic test
  • Result: The proportion of household members who developed influenza (1.9% vs 13.6%); well tolerated with no new safety signals identified
  • Xofluza inhibits the cap-dependent endonuclease in the PA protein and is a single-dose oral treatment for influenza which is different from all other currently available antiviral treatments

Click here ­to­ read full press release/ article | Ref: Shionogi | Image: Businesswire

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CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test

Shots:

  • Co-Diagnostics’ JV CoSara has received CDSCO’s clearance to manufacture and sell its Saragene COVID-19 2-gene multiplex RT-PCR test as an IVD, intended for the qualitative detection of the SARS-CoV-2 virus
  • The kit leverages CoPrimer technology & is based on a test originally designed by Co-Diagnostics, who secured CE marking for its Logix Smart SARS-CoV-2 multiplex test in Feb’2020
  • To identify the virus presence, both the tests target two gene markers of the SARS-CoV-2 genome i.e. RdRp and E-gene. Additionally, CoSara prior received CDSCO’s approval for RT-PCR tests for mycobacterium tuberculosis, malaria, hepatitis B & C and HPV to be manufactured & sold as IVDs in India

Click here ­to­ read full press release/ article | Ref: Co-Diagnostics | Image: Co-Diagnostics

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Y-mAbs’ Danyelza (naxitamab-gqgk) Receives the US FDA’s Approval for Neuroblastoma

Shots:

  • The US FDA has approved Danyelza (40mg/10ml) and is indicated in combination with GM-CSF for pediatric patients aged 1yrs. & older and adult patients with r/r high-risk neuroblastoma in the bone marrow
  • The indication is approved under accelerated approval regulation based on ORR and DOR. Continued approval for the indication may be contingent upon verification and description of clinical benefits in a confirmatory trial
  • Danyelza is a mAb that targets the ganglioside GD2 which is highly expressed in various neuroectoderm-derived tumors and sarcomas and has received PR, ODD, BT and RPD from the US FDA

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: y-mAbs

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CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI Brain Volumetric Reporting

Shots:

  • The US FDA has granted 510(k) clearance for CorticoMetrics’ AI-based software, THINQ, for MRI brain volumetric reporting. The software can provide radiologists & neurologists with quantitative to improve assessment of neurological disorders
  • The software can automatically segment T1-weighted MRI brain image, providing volumetric measurements & visualisations of 30 critical brain structures and compares the measures to age and gender-matched reference percentile data
  • Reporting includes images of the brain with color-coded segmentations, as well as plots showing how measurements compare to reference data

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Lify

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Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Shots:

  • The approval is based on P-lll DISCOVER-1 & -2 study assessing Tremfya (100mg q4w and q8w) vs PBO in 381 & 739 patients with active PsA who had an inadequate response to SOC &
  • Who were biologic-naïve only and had an inadequate response to SOC respectively
  • Combined results: achieved 1EPs of ACR20 @24wks.; improvements in quality of life scores; improvement in PASI 75, PASI 90, and PASI 100 rates. In DISCOVER-2 study, @24wks. less radiographic progression in both groups Tremfya is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of PsA and PsO

Click here ­to­ read full press release/ article | Ref: Janssen | Image: The Pharma Letter

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Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Shots:

  • The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients
  • The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to PBO, the study also achieved significant results for all 6 tested 2EPs
  • In ILLUMINATE-B, Oxlumo demonstrated a 72% mean reduction in spot urinary oxalate: creatinine ratio from baseline to 6mos., reduction of oxalate as consistent across all three body wt. categories. Additionally, therapy demonstrated positive results across 2EPs, including additional measures of oxalate

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Bloomberg

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BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Shots:

  • The approval is based on P-lll ATTRACTION-3 study involve the assessment of Opdivo vs CT (docetaxel or paclitaxel) for patients with esophageal cancer refractory/ intolerant to 1L combination therapy with fluoropyrimidine- and Pt.-based drugs
  • Results: reduction in risk of death (23%); m-OS (10.9 vs 8.4 mos.); @12 & 18-mos. OS rates (47% & 31% vs 34% & 21%); ORR (19% and 22%); DoR (6.9 vs 3.9 mos.)
  • Opdivo is a PD-1 immune checkpoint inhibitor, designed to harness the body’s immune system to help restore anti-tumor immune response and is the first immunotherapy to be approved for gastroesophageal cancer in the EU

Click here ­to­ read full press release/ article | Ref: Bristol Myers Squibb | Image: Bristol Myers Squibb

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Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

Shots:

  • The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test
  • Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals
  • Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person. Roche also plans to file sNDA for Xofluza as a treatment for acute uncomplicated influenza in pediatric patients (1-12yrs.) and for the prevention of influenza in the same age group who have been exposed to influenza

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: BioSpace

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Baxter’s Homechoice Claria APD System Receives the US FDA’s 510 (k) Clearance for Kidney Failure

Shots:

  • Baxter has received the FDA’s clearance for its APD system designed for home use, combining it with Sharesource that aims to help patients with kidney disease manage their care remotely
  • The Homechoice Claria system was cleared for both adults and children. Its interface is available in 38 languages and features step-by-step, voice-activated instructions through an app to guide the user through therapy
  • The clearance follows the recent finalization of the ESRD ETC payment model aims to increase the number of new patients with kidney failure who receive home dialysis and organ transplants. Homechoice Claria with Sharesource will be available in the US in the coming weeks

Click here ­to­ read full press release/ article | Ref: Baxter | Image: BusinessWire

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Eiger’s Zokinvy (lonafarnib) Receives the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Shots:

  • The Progeria Research Foundation and Eiger reported the US FDA’s approval of Zokinvy (lonafarnib) for the treatment of HGPS or progeria and processing-deficient progeroid laminopathies
  • Zokinvy reduced the incidence of mortality by 60% & increased the average survival time by 2.5 yrs. Additionally, the FDA has issued an RPD priority review voucher to Eiger
  • Eiger plans to sell the PRV and will share the proceeds equally with PRF, under its supply & collaboration agreement. Zokinvy is a farnesyltransferase inhibitor that has shown a survival benefit in children with Progeria

Click here ­to­ read full press release/ article | Ref: Eiger Bio | Image: PRNewswire

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Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Shots:

  • The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting
  • Results: reduction in viral load & rates of symptoms & hospitalization, frequency & types of AEs are similar
  • Health Canada authorized the therapy for the use of bamlanivimab (LY-CoV555) as a treatment for adults & pediatric patients aged≥12yrs. with mild to mod. COVID-19 who weigh at least 40 kg & are at high risk of progressing to severe COVID-19 illness or hospitalization

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Microbioz India

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Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Shots:

  • The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at least 40kg [~88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19
  • The EUA is based on a P-II study that showed a reduction in hospitalization or ER visits in patients at high risk for disease progression within 28days after treatment and a reduction in viral loads
  • Initial doses of Ab cocktail will be made available to ~300,000 patients, with no medication out-of-pocket costs, under the US government allocation program

Click here ­to­ read full press release/ article | Ref: Regeneron | Image: Fox Business

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Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19

Shots:

  • The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO with remdesivir in hospitalized patients with/ out oxygen requirements
  • Result: Median time to recovery from 8-7days (12.5% improvement), patients who progressed to ventilation (23% vs 28%), patients who died @day29 (4.7% vs 7.1%) with a relative reduction of 35%; better clinical status @day15
  • This marks the second Lilly therapy to be granted a EUA, in addition to neutralizing Ab EUA for high-risk non-hospitalized patients, increasing the number of treatment options for COVID-19 patients at different stages of the disease

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: CNBC

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Chiesi’s Bronchitol (mannitol) Inhalation Powder Receives the US FDA’s Approval for Cystic Fibrosis

Shots:

  • In the three large-scale global clinical trials assessing Bronchitol in 761 patients, sustained improvement in FEV1 (Forced Expiratory Volume) with Bronchitol use vs. control group was observed
  • Bronchitol is currently approved and marketed in Australia, Italy, Germany, Russia, and several other countries. Additionally, the company anticipates launching Bronchitol in the US in Mar 2021
  • Bronchitol (mannitol) inhalation powder is a sugar alcohol and also the 1st and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in CF patients aged 18 yrs. of age and older

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: StraitTimes

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Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

Shots:

  • The Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are suspected of COVID-19 by their HCPs
  • It is also authorized for use in POC settings for all ages, but samples must be collected by an HCP when the test is used at the POC to test individuals <14yrs. The test is currently authorized for prescription use only
  • Lucira plans to amend its EUA or file a new EUA so people who think they’re infected with COVID-19 can communicate with a medical professional online through a website to arrange a prescription and overnight delivery of the test kit by Q2’21

Click here ­to­ read full press release/ article | Ref: FDA | Image: MobileHealth News

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Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Shots:

  • The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU
  • The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and reduced the risk of influenza by an additional 30% in adults aged ≥50yrs.
  • Supemtek contains three times more antigen than both egg-based and cell-based standard-dose vaccines. Supemtek is also approved in the US under the tradename Flublok Quadrivalent

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Sanofi

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Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

Shots:

  • The US FDA accepted for priority review the BLA of avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. The target action date for the FDA decision is May 18, 2021
  • The BLA is based on positive data from two trials: P-III COMET study and P-II mini-COMET study and the results from both the studies were presented at World Muscle Society and the American Association of Neuromuscular & Electrodiagnostic Medicine and WORLDSymposium respectively
  • Avalglucosidase alfa is an investigational enzyme replacement therapy designed to improve the delivery of GAA enzyme to muscle cells, and it would become a potential new SoC for patients with Pompe disease (if approved)

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Sanofi

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ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Shots:

  • This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020)
  • Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing HIV compared to daily oral FTC/TDF tablets. The HIV incidence rate is 0.41% in the cabotegravir group and 1.22% in the FTC/TDF group
  • A partner HIV prevention study (HPTN 084) in sub-Saharan African women was stopped earlier this month based upon recommendation of the independent DSMB following the superioriority of cabotegravir to oral FTC/TDF tablets. The company plans to use the data from both the HPTN studies for future regulatory submissions

Click here ­to­ read full press release/ article | Ref: ViiV Healthcare | Image: ViiV Healthcare

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QBiotics’ Stelfonta (tigilanol tiglate) Receives the US FDA’s Approval as the First Treatment for Non-Metastatic MCT in Dogs

Shots:

  • The approval is based on a study supporting its safety, efficacy in dogs with a measurable cutaneous/ SC MCT on the lower leg and follows the EMA’s MAA granted in early 2020
  • Stelfonta provides 75% complete tumor resolution after just one injection, and dogs quickly regain pre-treatment QoL. The therapy will be launched in the US in the coming months and then made available to primary care veterinarians from early 2021
  • QBiotics is currently investigating Stelfonta in a series of human P-I & P-II clinical trials targeting solid tumors as both as monothx. and an immune checkpoint inhibitor combination therapy

Click here ­to­ read full press release/ article | Ref: QBiotics | Image: iStock

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Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza

Shots:

  • The EMA’s CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged ≥12yrs. Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged ≥12yrs.
  • The CHMP recommendation is based on the results of the P-III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies. The company is expecting the EC’s final decision in approval in the near future
  • Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein and is available in the US and in several other countries for influenza types A and B

Click here ­to­ read full press release/ article | Ref: Roche | Image: Tele trader

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Eisai’s Fycompa (perampanel) Receives EC’s Approval for Expanded Indication in Pediatric Patients with POS and PGTCS

Shots:

  • The approval extends the use of Fycompa as adjunctive therapy for POS (with/out secondary generalization) by expanding the approved age range from 12yrs.+ to 4yrs.+ and for PGTCS from 12yrs.+ to 7yrs.+
  • The approval is based on P-III 311 study assessing Fycompa (oral suspension) as adjunctive therapy in 180 pediatric patients (aged 4-12 yrs.) with POS or PGTCS
  • The 232 study involves assessing the PK, efficacy, and long-term safety of Fycompa taken at the same time as other AEDs therapy in 63 pediatric patients with epilepsy in patients aged 2 to >12yrs. Fycompa is an AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures

Click here­ to­ read full press release/ article | Ref: Eisai | Image: Pinterest

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Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

Shots:

  • The US FDA has granted FT designation to NVX-CoV2373 which is currently in late-phase clinical development. Novavax expects to initiate pivotal P-III study in the US & Mexico by the end of Nov’2020
  • The company’s ongoing P-lll trial in the UK to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of Nov. Depending on the overall COVID-19 attack rate, interim data in the UK trial is expected in Q1’21
  • NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant

Click here ­to­ read full press release/ article | Ref: Novavax | Image: Newsroom Keck Medicine of USC

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Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Shots:

  • The EUA is based on P-II BLAZE-1 study assessing bamlanivimab (700/2800/7000 mg) as monothx. vs PBO or in combination with second Ab for the treatment of symptomatic COVID-19 in the outpatient setting. The EUA is granted for bamlanivimab (LY-CoV555, 700 mg)
  • Patients showed reduced viral load & rates of symptoms & hospitalization. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions
  • The US government will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs for the medication. Bamlanivimab should be administered asap after a positive COVID-19 test and within 10 days of symptom onset

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: Business Standard

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AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Shots:

  • The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL
  • ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and 80%). ASCEND results: patients remained alive and free from disease progression @12mos. (88% vs 68%)
  • Calquence is a selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. The approval follows CHMP’s recommendation received in Jul’2020

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: CTV News

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AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Shots:

  • The approval is based on P-III THALES study involves assessing Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days
  • Results demonstrated a reduction in the rate of the composite 1EP of stroke & death by 17%, risk of severe bleeding events (0.5% vs 0.1%). Regulatory submissions to expand the approved indication are under regulatory review in China and the EU
  • Brilinta (ticagrelor) is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. The approval follows the US FDA’s PR designation granted in Jul’2020

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Pinterest

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AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Shots:

  • The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab
  • Results: reduction in risk of disease progression or death by 67%, PFS (37.2mos. vs 17.7mos.); PFS2 (50.3mos. vs 35.3mos.)
  • Following the approval, AZ will receive $25M as a regulatory milestone from MSD. The approval follows the CHMP’s positive opinion granted in Sept’2020

Click here to­ read the full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

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AstraZeneca’s Forxiga (dapagliflozin) Receives EC’s Approval for Heart Failure

Shots:

  • The approval is based on P-III DAPA-HF study involves assessing of Forxiga (10mg) + SOC vs PBO +SOC in 4744 patients with heart failure and reduced ejection fraction (LVEF ≤ 40%) with/out T2D
  • Results: reduction in risk of the composite outcome by 26%, with both components of the 1EPs (first occurrence of a worsening HF event or CV death) contributed benefit to the overall effect.
  • Forxiga is the first SGLT2 inhibitor approved in the EU for HFrEF in adult patients with/out T2D. The therapy is currently being evaluated for HFpEF in P-III DELIVER study with its anticipated results in H2’21

Click here to­ read the full press release/ article | Ref: AstraZeneca | Image: Health Quest Patient Center

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Abbott to Launch its Cardiac Mapping Platform in Europe and Australia

Shots:

  • The company has received CE mark in EU and approval in Australia for its new EnSite X EP system which offers the option to navigate the cardiac anatomy in two different ways on one platform.
  • The system can create a 3D model of the patient’s cardiac anatomy in real time and will enable physicians to spot areas of the heart that need ablation treatment. The system is currently pending 510(k) clearance from the US FDA
  • Additionally, the company has received the US FDA & CE mark approval for the EnSite LiveView Dynamic Display, which allows data from the Advisor HD Grid mapping catheter, Sensor Enabled to be visualized in real-time during cardiac ablation procedures

Click here to­ read the full press release/ article | Ref: Abbott | Image: PCR News

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Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA

Shots:

  • The approval is based on the RANGER II SFA pivotal study assessing the Ranger DCB vs standard PTA for the treatment in patients with PAD in the SFA & PPA
  • The study met its both 1EPs @12mos. i.e. MAE (94.1% vs 83.5%); lesion revascularization rate (5.5% vs 16.5%); Binary primary patency (82.9% vs 66.3%); primary patency by Kaplan-Meier estimate (89.8% vs 74.0%). The DCB has demonstrated 90% primary patency in COMPARE trial
  • The company expects to initiate a registry of the Ranger DCB and the Eluvia stent in the coming months to gather additional RWE and plans to launch the device in the US

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: Forbes

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Roche’s Tecentriq (atezolizumab) + Avastin (bevacizumab) Receive the EC’s Approval for Unresectable Hepatocellular Carcinoma

Shots:

  • The approval is based on P-III IMbrave150 study involves assessing of Tecentriq (atezolizumab, 1200mg) + Avastin (bevacizumab, 15 mg/kg) on day 1 of each 21-day cycle vs sorafenib (400mg, bid) on days 1-21 of each 21-day cycle in 501 patients in a ratio (2:1) with unresectable HCC, prior not treated with systemic therapies
  • Result: reduction in the risk of OS (42%); reduction in the risk of disease worsening or death, PFS (41%); showed improvement in both OS and PFS; Grade 3–4 AEs (57% vs 55%), published in the NEJM
  • The approval follows an EMA’s CHMP positive opinion received in Sept’2020. The dual regimen also recently included as a class I, A recommendation by the ESMO for unresectable HCC, as well as by many clinical practice guidelines globally

Click here to­ read the full press release/ article | Ref: Roche | Image: National Foundation For Cancer Research

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Medtronic Expands ENT Portfolio with the Acquisition of Ai Biomed and the Approval of NIM Vital Nerve Monitoring System

Shots:

  • Medtronic has expanded its portfolio of technologies focusing on improving the safety of head and neck surgeries with the acquisition of Ai Biomed and the US FDA’s 510(k) clearance of NIM Vital nerve monitoring system
  • The NIM Vital nerve monitoring system enables physicians to identify, confirm, and monitor nerve function to help reduce the risk of nerve damage during head and neck surgery
  • The acquisition marks the 7th acquisition by Medtronic in 2020. The acquisition will add the PTeye laser system to Medtronic’s ENT portfolio which a tissue-detecting probe used in thyroid surgery

Click here to­ read the full press release/ article | Ref: Medtronic | Image: Market Watch

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GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

Shots:

  • The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count
  • Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula reduced the risk of disease progression or death vs. pbo by 57% and the risk of disease progression or death vs. pbo by 38% in the overall population. Additionally, risk of progression in those with BRCA mutation tumours showed 60% reduction
  • Zejula is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. It is the first PARP inhibitor approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer

Click here to­ read the full press release/ article | Ref: Abbvie | Image: Spiegel

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AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study

Shots:

  • The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries
  • The study demonstrated that Forxiga achieved a significant reduction in the composite EP of hHF or CV death. The trial confirmed the well-established safety profile of Forxiga
  • The NMPA’s label update follows the update to the EU MAA in Aug’2019 and the US FDA’s approval granted in Oct’2019

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

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Medtronic’s Abre Venous Stent Receives the US FDA’s Approval to Treat Venous Outflow Obstruction

Shots:

  • The approval is based on ABRE clinical study assessing the Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with the post-thrombotic syndrome, NIVL & those who presented with an aDVT. The study also includes a challenging patient population, 44% of whom required stents that extended below the inguinal ligament into the CFV
  • The study resulted in meeting its 1EP of safety with a 2% rate of MAEs within 30 days and also met its 1EPs of efficacy with an overall primary patency rate of 88.0%, no stent fractures, and no stent migrations were reported in the study.
  • Abre venous self-expanding stent system is the device, indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction and has received CE Mark approval in April’2017

Click here ­to­ read full press release/ article | Ref: Medtronic | Image: elEconomista.es

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Foundation Medicine’s FoundationOne CDx Receives the US FDA’s Approval as a CDx for Vitrakvi (larotrectinib)

Shots:

  • The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. The genomic test is currently approved as a CDx for 20+ therapies
  • The FoundationOne CDx is the tissue-based CGP test approved to detect NTRK1/2/3 fusions across all solid tumor types and identify patients who may be appropriate for treatment with Vitrakvi
  • The approval of Vitrakvi was based on three studies including LOXO-TRK-14001,  SCOUT, and NAVIGATE studies and is indicated for the treatment of adult and pediatric patients with solid tumors that have NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Clinical OMICs

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UCB’s Vimpat (lacosamide) Receives CHMP’s Positive Opinion for Primary Generalized Tonic-Clonic Seizures

Shots:

  • The EMA’s CHMP has adopted a positive opinion on a license extension for Vimpat (lacosamide) and Lacosamide UCB (lacosamide) as an adjunctive therapy in the treatment for PGTCS in adults, adolescents, and children from 4 years of age with idiopathic generalized epilepsy
  • The CHMP’s positive opinion is based on P-lll study assessing lacosamide as an adjunctive treatment for uncontrolled PGTCS. The therapy lowered the risk of developing a second PGTCS during a 24wks. period and demonstrated a higher rate of freedom from PGTCS during the treatment period
  • The company expects the EC’s formal approval decision before the end of 2020, that broaden the clinical application of Vimpat and make a new treatment option available to aid the management of PGTCS

Click here ­to­ read full press release/ article | Ref: UCB | Image: BioExcel

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Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

Shots:

  • The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
  • ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
  • Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the first and only approved COVID-19 treatment in the United States.

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Los Angeles Times

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Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

Shots:

  • The US FDA has granted ODD for branaplam in HD. In preclinical trials, branaplam demonstrated a reduction in levels of the mutant huntingtin protein. Additionally, the therapy showed a reduction in huntingtin mRNA in SMA patients
  • Novartis expects to initiate the P-IIb study for branaplam in HD patients in 2021
  • Branaplam (qw, PO) is an RNA splicing modulator, currently under investigation for the treatment of SMA

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Pfarma

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Lilly’s Taltz (ixekizumab) Receives Health Canada Approval for Non-Radiographic Axial Spondyloarthritis

Shots:

  • The approval is based on P-lll COAST-X study assessing Taltz (80mg, q4w) vs PBO for the treatment of adult patients with nr-axSpA with objective signs of inflammation for 52wks.
  • Result: 1EPs of ASAS40 @16wks. (35% vs 19%); ASAS40 [email protected] (30% vs 13%), met its 2EPs, showing efficacy in reducing disease activity and sacroiliac joint inflammation, improving patient function & QoL, the safety profile is consistent with the previous study
  • Taltz is a mAb that selectively binds with IL-17A cytokine and inhibits its interaction with the IL-17 receptor

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Everyday Health

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Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma

Shots:

  • The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with 3L treatment and at least 2L therapies including lenalidomide and a proteasome inhibitor with RRMM in 307 patients with RRMM
  • The study demonstrated that the combination regimen demonstrated a reduction in risk of disease progression or death in adults by 40%, mPFS (11.5 vs 6.5), well-tolerated with no increase in treatment discontinuation
  • Isatuximab is a mAb that binds to a specific site on CD38 and is now available to eligible patients through the NHS Cancer Drugs Fund. Isatuximab is the first mAb approved in EU to be used in combination with pom-dex for RRMM

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Bloomberg

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Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA)

Shots:

  • The CHMP’s positive opinion is based on P-III DISCOVER-1 & -2 studies assessing guselkumab (100 mg, q4w/q8w) vs PBO in 381 & 739 patients with active PsA & patients who were biologic-naïve only & who had an inadequate response to standard therapies respectively
  • Combined results: @24wks. improvement in ACR (20%); improvements in quality of life scores SF36; higher PASI 75, PASI 90, and PASI 100 response rate were observed. In both studies, Tremfya was generally well tolerated through study completion
  • Guselkumab is the first approved mAb that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. If approved, guselkumab will be the first selective (IL)-23 p19 subunit inhibitor licensed for both PsA and moderate to severe PsO

Click here ­to­ read full press release/ article | Ref: Janssen | Image: PMLive

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AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia

Shots:

  • The approval is based on P-lll VIALE-A & VIALE-C studies and updated data from the P-Ib M14-358 and the P-I/II M14-387 studies. The P-III studies involve assessing of Venclexta (400mg & 600mg, qd) + azacitidine & LDAC vs PBO + azacitidine & LDAC in 431 & 211 people with previously untreated AML who are ineligible for intensive CT respectively
  • VIALE-A results: Reduction in the risk of death (34%), m-OS (14.7 vs 9.6mos.), CR rate (37% vs 18%); CR+CRh rate (65% vs 23%), median duration (7.6 mos.). VIALE-C results: CR rate (27% vs 7.4%); DOCR (11.1mos. vs 8.3mos.); m-OS (7.2mos. vs 4.1mos.). In 2018, the US FDA has granted accelerated approval for AML
  • This is the second time that Venclexta has been reviewed under the FDA’s new RTOR and Assessment Aid pilot program. Additionally, the FDA has granted five BTD for Venclexta, two of which are for people with previously untreated AML ineligible for intensive CT

Source 1, Source 2 ­to­ read full press release/ article | Ref: Abbvie & Roche | Image: Leukemia & Lymphoma Society

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Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

Shots:

  • The CHMP’s positive opinion is based on ORION program including P-III studies assessing Leqvio in 3,600+ patients on a maximally tolerated statin dose. Inclisiran demonstrated effective and sustained LDL-C reduction of up to 52% with 2doses/yr, after an initial dose and one @3mos., in adults with ASCVD, ASCVD risk equivalent or HeFH6
  • 80% of high-risk patients do not reach guideline-recommended LDC-L, targets despite the widespread use of statins. Reduction in LDL-C was achieved through 17mos. with a safety and tolerability profile like PBO
  • Additional post hoc analysis demonstrated 88% of them reached guideline-recommended targets at any timepoint during the study. Additionally, the therapy is also under review by the US FDA and other health authorities for primary hyperlipidemia in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Easy Health Options

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Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Shots:

  • Health Canada has approved Luxturna (voretigene neparvovec) as a one-time gene therapy for the treatment of adult & pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells
  • Luxturna is designed to provide functioning copies of the RPE65 gene to act in place of mutated RPE65 genes. The functioning genes work to restore vision and improve sight, giving patients the potential for greater independence
  • Novartis has entered a partnership with Blueprint Genetics to facilitate the genetic testing where appropriate to validate the diagnosis

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Technologies

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Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Shots:

  • The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a ratio (1:1) with r/r cHL after at least one multi-agent CT regimen
  • Results: reduction in the risk of disease progression or death by 35%, median PFS (13.2mos. vs 3mos); ORR (66% vs 54%); DOR (20.7 mos. vs 13.8mos.). The approval is reviewed under the FDA’s Project Orbis
  • Ketruda is a humanized mAb that blocks the interaction between PD-1 and its ligands, PD-L1 & PD-L2 thus activating T lymphocytes that affect tumor cells & healthy cells. Additionally, the US FDA has approved an updated pediatric indication for refractory cHL or cHL that has relapsed after two or more lines of therapy

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: Fortune

The post Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma first appeared on PharmaShots.

Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Shots:

  • The P-II study will evaluate STI-5656 in ~400 patients hospitalized due to COVID-19 having mild, moderate, and severe symptoms. The P-II clinical trials of abivertinib now cleared to proceed in both Brazil and the US
  • The dose to be tested is the same as in the US P-II trial but the trial protocol in Brazil includes patients at earlier stages of the disease, with a drug administration regimen of 7 days (versus 14 days for more advanced patients in the US)
  • Both the studies are complementary and address both dose duration and disease stage

    Click here to­ read the full press release/ article | Ref: Sorrento Image: Newsmax

The post Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil first appeared on PharmaShots.

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Shots:

  • The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
  • As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA.
  • Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein

    Click here to­ read the full press release/ article | Ref: PR Newswire | Image: Stat

The post Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola first appeared on PharmaShots.

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

Shots:

  • The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status
  • The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to 1L Pt.-based CT
  • Zejula (PO, qc) is a poly (ADP-ribose) polymerase (PARP) inhibitor and has received approval in 2019, in Canada for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer

Click here ­to­ read full press release/ article | Ref: GSK | Image: Pharmafile

The post GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer first appeared on PharmaShots.

Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Shots:

  • The US FDA has granted ODD and RPD to the Taysha Gene Therapies’ TSHA-101 for GM2 Gangliosidosis. The company expects the therapy to enter the clinic by the end of 2020
  • The US FDA’s two designations demonstrated the strength of the translational data package supporting TSHA-101 for GM2 Gangliosidosis
  • TSHA-101 is an AAV9-based gene therapy, currently under development for rare, neurodegenerative disease that causes a progressive dysfunction of the CNS

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Nordic Life Science

Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

Shots:

  • The US FDA and EMA has received ODD to Galecto’s GB0139 for the treatment of IPF. GB0139 showed significant reduction of YKL-40 biomarker in fibrosis, inflammation, tissue remodeling diseases in its first clinical study after 14 days of treatment
  • The EMA cited GB0139’s clinically relevant biomarker data in IPF patients which provides financial incentives, encouraging the development of drugs targeting rare diseases
  • GB0139 (formerly TD139) is an inhaled galectin-3 inhibitor, being evaluated in P-IIb GALACTIC-1 study in 450 patients with IP across 100 centers in the US the EU and Canada

Click here, ­to­ read full press release/ article | Ref: PRNewswire | Image: Galecto

Abbott’s BinaxNOW COVID-19 Ag Card Receives the US FDA’s EUA to Detect SARS-CoV-2 Infection

Shots:

  • The US FDA has issued EUA for Abbott’s BinaxNOW COVID-19 Ag Card rapid test for the detection of COVID-19. The test will be available at $5 and can deliver results in 15mins.
  • The test utilizes lateral flow technology and has demonstrated a sensitivity of 97.1% and specificity of 98.5% in a clinical study. Additionally, the company has launched the complementary phone app (NAVICA), allowing people to display their BinaxNOW test results in any organizations where people gather like workplaces and schools
  • The BinaxNOW COVID-19 Ag Card can be used as a 1L of defense to identify infected people. The company anticipates shipping of ~10M tests in Sept, ramping to 50M tests/ month at the beginning of Oct’2020

Click here ­to­ read full press release/ article | Ref: Abbott | Image: Alere

GSK’s Blenrep (belantamab mafodotin) Receives EC’s Approval for R/R Multiple Myeloma

Shots:

  • The EC’s approval is based on DREAMM-2 study assessing Blenrep (2.5/ 3.4 mg/kg, q3w) as monothx. in adult patients prior treated with 4 therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 mAb, and who have demonstrated disease progression on the last therapy
  • The data demonstrated that Blenrep (2.5 mg/kg dose, q3w) resulted in 32% ORR, mDoR (11mos.) & mOS (13.7mos.) while the safety and tolerability profile is consistent with previous data of the therapy
  • Blenrep is a BCMA mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker and has received EMA’s PRIME designation in 2017

Click here ­to­ read full press release/ article | Ref: GSK | Image: StraitTimes

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Shots:

  • The first approval is for certain ESCC patients, which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.)
  • Additionally, Keytruda received approval for use at an additional recommended dosage of 400mg, q6w, IV over 30 minutes across all adult indications, including both monothx. and combination therapy
  • The approval for q6w dosing regimen is based on PK modeling and exposure-response analyses & was supported by an interim analysis of KEYNOTE-555 from a cohort of patients (Cohort B) treated with Keytruda (400mg, q6w). With the approvals, Keytruda has 13 indications across seven tumor types plus MSI-H tumors in Japan

Click here ­to­ read full press release/ article | Ref: Merck | Image: Biospace

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Shots:

  • The approval is based on P-III KATHERINE study assessing Kadcyla (100/160mg, IV) adjuvant therapy in 1486 patients with HER2+ early BC who did not have pathologic complete response following neoadjuvant therapy including Herceptin
  • The results showed the superiority of Kadcyla over Herceptin in terms of the 1EPs of invasive disease-free survival. The safety profile of the therapy in the study was consistent with the previously approved treatment of HER2-positive metastatic BC, and was well-tolerated as an adjuvant treatment in HER2-positive early BC
  • Kadcyla is an ADC and a postoperative new treatment option to improve prognosis in the treatment of HER2-positive early BC when pCR is not obtained by neoadjuvant therapy

Click here ­to­ read full press release/ article | Ref: Chugai | Image: Pune365

Related News: Roche’s Kadcyla (trastuzumab emtansine) Receives Health Canada’s Approval for The Treatment of HER2-Positive Early Breast Cancer After Surgery

AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Shots:

  • The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for 4 cycles) while in combination with CT and then q4w until disease progression
  • Results: the study met its 1EPs of OS in Jun’2019, demonstrated a 27% reduction in risk of death with m-OS (13.0 vs 10.3 mos.); ORR (68% vs 58%). An updated analysis demonstrated sustained efficacy after a median follow up 2+ yrs., m-OS (12.9 vs 10.5 mos.)
  • Imfinzi is a mAb targeting PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Clinical Lab Products

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Shots:

  • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
  • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22) & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
  • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

Click here ­to­ read full press release/ article | Ref: Novartis | Image: KRCU

MC2 Therapeutics Wynzora Cream Receives the US FDA’s Approval to Treat Plaque Psoriasis in Adults

  • The approval is based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults 18 years of age or older
  • The study resulted in a PGA treatment of 21.6% vs 14.6%, patients achieved at least a 4-point improvement in the peak pruritus NRS score at @4wks. 60.3% vs 21.4%
  • Wynzora is a novel topical solution offering high efficacy, favorable safety and excellent and is filled for MAA application in EU

Click here ­to­ read full press release/ article | Ref: MC2 Therapeutics | Image: MC2 Therapeutics

Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

Shots:

  • The Health Canada has approved a new indication as an add-on maintenance treatment with intranasal corticosteroids in patients with CRSwNP, inadequately controlled by systemic corticosteroids or surgery
  • The approval is based on P-III studies (24wks. SINUS-24 and 52wks. SINUS-52) assessing Dupixent (300mg, q2w) + SOC intranasal corticosteroids vs PBO + intranasal corticosteroids. The studies demonstrated improvement in its 1EPs and 2EPs @24wks.
  • The approval makes the Dupixent first approved biologic in Canada for CRSwNP. Dupixent is a fully mAb inhibiting the signaling of the IL-4 and IL-13 proteins and is not an immunosuppressant

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: CHE Manager

AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

Shots:

  • The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer, consistent with the approved dosing in ES-SCLC
  • The company anticipates the PDUFA date in Q4’20. The sBLA is based on multiple clinical trials, including results of P-III CASPIAN trial in ES-SCLC which used the 4wks., FD regimen during maintenance
  • If approved, the new dosing will be available as an alternative to the approved weight-based dosing of 10mg/kg q2w

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Fierce Pharma

Related News: AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III CASPIAN Study as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Shots:

  • The approval is supported by P-III SAkuraStar and SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx. & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 &  13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD respectively
  • The studies demonstrated robust efficacy and a favorable safety profile in adults with AQP4 Ab positive NMOSD. relapse-free patients @96wks. (76.5% & 91.1% vs 41.1% & 56.8%)
  • Enspryng is the first and only FDA-approved SC treatment option for AQP4 Ab positive NMOSD that can be self-administered by a patient or a caregiver every four weeks. The therapy is mAb targeting IL-6 that utilizes recycling antibody technology and will be available in the US in two wks.

Click here ­to­ read full press release/ article | Ref: Roche | Image: HKU E-Learning Platform

Related Post: Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

Shots:

  • On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac
  • Henlius followed the NMPA and EMA’s biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, Herceptin
  • Analytical studies, preclinical studies, P-I study, and a P-III study showed that HLX02 is highly similar to the reference in terms of quality, safety, and efficacy. Additionally, HLX01 (biosimilar, rituximab) received NMPA’s approval in 2019

Click here to­ read full press release/ article | Ref: PRNewswire | Image: GMP News

Related News: Henlius Reports Positive Results of HLX04 (biosimilar, bevacizumab) in P-III Trial for Metastatic Colorectal Cancer

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Shots:

  • The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC
  • The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about the patient’s tumor and ii) NGS that uses large-panel genetic sequencing, allowing clinicians to better assess tumor composition
  • Today’s approval is specific to its use in identifying NSCLC patients with EGFR alterations who may benefit from AstraZeneca’s Tagrisso. The assay has also received FDA’s breakthrough device designation

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Medpage Today

Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Shots:

  • The US FDA has approved Evrysdi to treat SMA in adults and children ≥ 2mos. The approval is based on two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2-7 mos, and SUNFISH in children and adults aged 2-25yrs.
  • The two studies demonstrated improvements in motor function in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA. The filing of MAA to EMA for the therapy is imminent while the therapy has been filed in Brazil, Chile, China, Indonesia, Russia, South Korea, and Taiwan
  • Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics and is the only therapy for SMA that can be taken at home. It will be available in the US within 2wks. for direct delivery to patients’ homes through Accredo Health Group

Click here ­to­ read full press release/ article | Ref: Roche | Image: PharmaShots

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

Shots:

  • The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs
  • The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments but for high throughput testing, an automated version of the assay is used for the optimization  of a workflow consisting of the Sentosa SX101 instrument, in conjunction with ABI 7500 Fast Dx PCR instrument or the Sentosa SA201 instrument
  • ViroKey SARS-CoV-2 RT-PCR Test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority

Click here ­to­ read full press release/ article | Ref: Vela Diagnostic | Image: Biospectrum Asia




UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum

Shots:

  • The P-IIIb C-OPTIMISE study assessing Cimzia (200mg, q2w with a loading dose of 400mg @ 0, 2 & 4wks.) vs PBO during 48wks. open-label induction period in adults with early active axSpA. At 48wks., patients in sustained remission (ASDAS <1.3 @wks. 32/36 & 48) were randomized to Cimzia 200mg, q2w (full maintenance dose) & 200mg q4w (reduced maintenance dose) or PBO (withdrawal) for an additional 48wks.
  • The EMA label extension is based on the results of the C-OPTIMISE study that demonstrated @48wks. 43.9% of patients achieved sustained remission, @96wks. 84%, 79% & 20% of patients receiving the full maintenance dose, reduced maintenance dose or PBO respectively remained flare-free
  • The approval makes Cimzia the only biologic in EU with a dose reduction option in its label for patients in the broad axSpA population

Click here ­to­ read full press release/ article | Ref: UCB | Image: CHE Manager




Roche’s cobas Epstein-Barr Virus Test Receives the US FDA’s Authorization for Transplant Patients

Shots:

  • The US FDA has granted de novo class II for cobas EBV test, providing HCPs a tool for monitoring transplant patients at risk for complications from infections or reactivations of EBV
  • The cobas EBV test is a PCR viral load test that runs on the fully automated and widely available cobas 6800/8800 systems and has been calibrated to WHO’s international standard
  • The test has received the FDA’s BDD and has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL-1E+08 IU/mL in EDTA plasma

Click here ­to­ read full press release/ article | Ref: Roche | Image: Fedaiisf




LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

Shots:

  • The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE
  • The FDA’s FT designation facilitates the development and expedites the regulatory review of drugs to treat serious conditions and demonstrate the potential to address an unmet medical need
  • Delgocitinib (bid, topical formulation) acts by inhibiting the activation of the JAK-STAT pathway, currently being evaluated in two P-IIb studies for mild-to-severe CHE & AD. The company plans to submit the results of P-IIb CHE study in late 2020

Click here ­to­ read full press release/ article | Ref: LEO Pharma | Image: LEO Pharma




Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

Shots:

  • The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients
  • The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile compared with Darzalex IV in patients with RRMS, 2/3rd reduction in systemic ARRs (13% vs 34%)
  • In P-II PLEIADES study evaluates Darzalex SC + D-VMP in newly diagnosed transplant-ineligible patients & Darzalex SC + (D-Rd) in R/R patients prior treated with 1L therapy. In general, Darzalex SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Explore




Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Shots:

  • The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients
  • Result: in NTRK fusion+ solid tumors, ORR (63.5%); mDoR (12.9mos.); In ROS1+ advanced NSCLC, shrank tumors in 73.4% of patients; DoR of 16.5mos. (14.6-28.6mos.); ORR (67.1%); in patients with CNS metastases with an intracranial ORR (62.5% & 77.8%); In pediatric patients, Rozlytrek shrank tumors in all children and adolescents who had NTRK gene fusions with two achieving a CR
  • Rozlytrek (entrectinib, qd) is a tumor-agnostic treatment for LA/m-solid tumors harboring NTRK1/2/3 or ROS1 gene fusions and has received EMA’s PRIME designation to treat NTRK fusion-positive, LA/m- solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Shots:

  • The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a CDx for Herceptin (trastuzumab) therapy. The assay was launched as a CE IVD in Apr’2019
  • The assay is designed to be completed within the same day, enabling clinicians to get results back faster than with other common methods of confirmatory testing for HER2
  • The assay is optimized for use with the VENTANA Silver ISH DNP detection kit and the VENTANA Red ISH DIG detection kit on the fully automated BenchMark ULTRA and is the enhanced version of the previous-generation test

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Shots:

  • The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS
  • The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile. The designation addresses the needs of people living with HR-MDS, for whom few therapies exist, and the benefits are limited
  • Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor. The pre-clinical studies demonstrated the inhibition of NAE, blocked the modification of select proteins, which resulted in the disruption of cell cycle progression and cell survival, leading to cancer cell death

Click here ­to­ read full press release/ article | Ref: Takeda | Image: Future Medicine India




Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots:

  • The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma
  • Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. The review was conducted under Project Orbis
  • Tecentriq is a mAb targeting PD-L1, acts by blocking is its interactions with both PD-1 and B7.1 receptor. Cotellic is a MEK1/2 inhibitor in a cell signaling pathway that helps control cell growth and survival while Zelboraf is a prescription medicine for melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Shots:

  • The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the US, EU, South America, Asia, and the Middle East
  • The study resulted in improvement in DFS, reduction in risk of disease recurrence, or death by 79% in the adjuvant treatment of Stage IB-IIIA EGFRm NSCLC patients, also presented at ASCO 2020. Additionally, the trial will continue to assess OS
  • Tagrisso (osimertinib) is third-generation, irreversible EGFR-TKI once-daily oral tablets approved 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC in the US, Japan, China, the EU

Click here to read full press release/ article | Ref: AstraZeneca | Image: Behance




Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Shots:

  • The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin
  • Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and a global multi-center P-III clinical study
  • Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

Click here to read full press release/ article | Ref: Henlius | Image: Behance




UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Shots:

  • The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data in children. Additionally, the safety and tolerability data of Brivlera in children 4 years and older were similar to observed in adults
  • The usage of Brivlera in pediatric and adolescent patients is supported by the placebo-controlled partial-onset seizure studies in adults, PK study in pediatric aged 4 to 17 years of and for the achievement of similar plasma concentrations as of adults weight-based dose adaptations were practiced
  • Brivlera is an anti-epileptic drug (AED) displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) developing anticonvulsant effects, approved by Health Canada as adjunctive therapy for partial-onset seizures in patients 4 years of age and older

Click here to read full press release/ article | Ref: Newswire | Image: Twitter




Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Shots:

  • The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required
  • The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical evidence indicating that the medicine may provide a substantial improvement over available therapy on at least one clinically significant endpoint
  • MK-6482 (formerly PT2977) is an investigational oral HIF-2α inhibitor, currently being evaluated in a P-III  trial in advanced RCC (NCT04195750), a P-II trial in VHL-associated RCC (NCT03401788), and a P-I/II dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738)

Click here ­to­ read full press release/ article | Ref: Merck | Image: Market Watch




Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

Shots:

  • The US FDA has granted 510 (k) clearance to HealthMammo for boosting early detection of breast cancer in mammograms
  • The tool utilizes the AI to prioritize and identify suspicious mammograms and is automatically sent to Zebra’s platform, where it gets processed and analyzed for suspected breast lesions. The HealthMammo product then returns its result to the radiologist
  • Zebra Medical’s HealthMammo may help radiologists deal with the screening management strategy of the post COVID backlog and triaging. The tool is the first solution for oncology to receive FDA clearance, as part of the company’s AI1 “All-In-One” bundle

Click here ­to­ read full press release/ article | Ref: Business wire | Image: Business wire




Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Shots:

  • The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
  • Results: 87% patients responded to Tecartus (single infusion), including 62 % patients achieved CR, 18% experienced Grade 3 or higher CRS and 37% experienced Grade 3 or higher neurologic toxicities
  • Tecartus is an autologous, anti-CD19 CAR T cell therapy, currently under EC review and has received EMA’s PRIME designation for r/r MCL. The therapy will be manufactured in Kite’s commercial manufacturing facility in El Segundo, California

Click here to read full press release/ article | Ref: Kite | Image:  Stat News




Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Shots:

  • The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
  • Equidacent will be available as 25 mg/ml as the solution for infusion targeting VEGF and act by inhibiting the binding of VEGF to its receptors on endothelial cell
  • The company anticipates EC’s decision in ~60days. The clinical data demonstrated that Equidacent has comparable quality, safety, and efficacy to Avastin

Click here to read full press release/ article | Ref: PRNewswire | Image: PharmaShots




AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Shots:

  • The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with mod. to sev. COPD and a history of exacerbation(s) in the previous year
  • The P-III ETHOS study demonstrated a reduction in the rate of moderate or severe exacerbations. Additionally, the P-III KRONOS study also support the approval of the therapy
  • Breztri Aerosphere is an approved therapy in Japan and China for patients with COPD and is under regulatory review in the EU. As per the agreement to acquire Pearl Therapeutics, AstraZeneca paid $150M as a milestone on US approval of the therapy for COPD

Click here to read full press release/ article | Ref: AstraZeneca | Image: 

Related News: AstraZeneca Reports Results of Breztri Aerosphere in P-III ETHOS Study to Treat COPD




Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Shots:

  • The US FDA approves Abbott’s patient controller app for use on Apple’s smartphone devices, allowing patients with neurological conditions such as chronic pain or movement disorders to manage their therapy directly from their smartphone
  • The company plans to integrate the app into Abbott’s NeuroSphere Digital Care, launched in May’2020 which is compatible with Infinity DBS System for patients with PD or essential tremor, Proclaim XR SCS system and Proclaim DRG Neurostimulation system for patients with chronic pain and chronic pain in the lower limbs caused by complex regional pain syndrome or causalgia respectively
  • The integration across all Abbott neuromodulation technologies allows physicians to treat patients more easily within their practice who have an Abbott device and Apple smartphone. The patient controller app with personalized access to therapy will be available imminently

Click here to read full press release/ article | Ref: Abbott | Image: Twaku




Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Shots:

  • The approval is based on 12mos. results of PINNACLE FLX study assessing the WATCHMAN FLX device as an alternative to NOACs and other OAC medications. The study met its 1EPs demonstrating a low rate of major procedure-related safety events (0.5% @7days post-procedure) and high rate of effective LAAC (100% with peri-device flow < 5mm @12mos. post-procedure) and showed a high implant success rate of 98.8%
  • The company is also evaluating the device in OPTION study for patients with NVAF undergoing cardiac ablation procedure comparing it to oral anticoagulants as well as in the CHAMPION-AF trial that assess the device against NOACs in a broader OAC-eligible patient population
  • The WATCHMAN FLX device is indicated to reduce the risk of stroke in patients with NVAF by permanently closing off the left atrial appendage and is available in broader size options to treat a wider range of patient anatomies. The device receives CE mark in Mar’2019 and will immediately commence a launch of the device in the US

Click here to read full press release/ article | Ref: Businesswire | Image: Boston Scientific




Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Shots

  • The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future
  • In Nov’2019, FullFocus received the CE Mark, making it available to use in the EU. Paige has early access trials across the US, EU, and Brazil with healthcare organizations to serve patients and maintains a business continuity
  • FullFocus operates within the Paige Platform and allows users, meaning researchers and pathologists to view any digital image, regardless of the scanning platform used to generate the image

Click here to read full press release/ article | Ref: Businesswire | Image: Paige




Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Shots:

  • The US FDA has authorized Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to 4 individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples
  • Quest Diagnostic expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow
  • The company has received the FDA’s EUA for use of self-collection molecular diagnostic kit on the Hologic and Roche’s platforms, expanding use with healthcare provider supervision via telemedicine

Click here to read full press release/ article | Ref: PRNewswire | Image: Glassdoor




Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Shots:

  • The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis, which includes recurrent pericarditis. The company plans to submit sBLA in recurrent pericarditis to the US FDA in late 2020
  • Earlier, the company has reported the results of P-III RHAPSODY study that met its all 1EPs & 2EPs showing that the therapy improved clinical outcomes associated with the unmet medical need in recurrent pericarditis
  • Rilonacept (SC, qw) is a recombinant fusion protein that blocks IL-1α and IL-1β signaling and has received the US FDA’s BT designation in 2019. In 2017, Regeneron out-licensed rilonacept to Kiniksa for recurrent pericarditis under which Regeneron will receive equal profit on sales of the therapy, if approved in the US

Click here to read full press release/ article | Ref: Kiniksa | Image: Kiniksa




BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

Shots:

  • The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months
  • The study resulted in ORR as 76.9% and CR as 61.5% with no fatal adverse reactions. BieGene’s Tislelizumab is the first drug to be approved in China and the candidate’s NDA has also received NMPA’s Priority Review while BeiGene is currently working with BI for its commercial supply to launch in China
  • Tislelizumab (BGB-A317, 200mg, IV) is a humanized IgG4 anti–PD-1 mAb targeted to minimize binding to FcγR on macrophages and is been evaluated as a monothx and in combination to treat multiple solid tumor and hematologic cancers with 15 registration-enabling trials conducted in China and globally, including 11 P-III trials and 4 pivotal P-II trials

Click here to read full press release/ article | Ref: BeiGene | Image: Twitter

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy for Patients with Recurrent Ovarian Cancer in China

Shots:

  • Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
  • The NMPA approval of Zejula is novel product approved in Mainland China, has shown 73% reduction in risk of disease progression and death in patients with germline BRCA mutations and 55% in patients without germline BRCA mutations with expected for sNDA submission to the NMPA for 1L monothx maintenance treatment of platinum-responsive ovarian cancer patients
  • The candidate has also received priority review status on Jan 29, 2019 and is also evaluated in NORA study for Chinese patients with recurrent ovarian cancer plus expected completion in Q3’20. Zai Lab in-licensed exclusive rights to commercialize Zejula in Mainland China, Hong Kong, and Macau from GSK

Click here to read full press release/ article | Ref: GlobeNewsWire | Image: Signbox